In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.

Incidence of new infection during ICU stay [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Duration of ICU dependency (crude stay days and time to alive discharge from ICU) [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: during ICU stay, hospital stay and up to 90 days post-randomization ] [ Designated as safety issue: Yes ]

Time to alive discharge from hospital [ Time Frame: during hospital stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Incidence of hypoglycaemia during ICU stay [ Time Frame: during the intervention window up to day 8 post-randomization ] [ Designated as safety issue: Yes ]

Time to final weaning from mechanical respiratory support [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Incidence of liver dysfunction during ICU stay [ Time Frame: during ICU stay and up 90 days post-randomization ] [ Designated as safety issue: No ]

Need for haemodynamic support during ICU stay [ Time Frame: during ICU stay and up 90 days post-randomization ] [ Designated as safety issue: No ]

Incidence of new kidney injury during ICU stay [ Time Frame: during ICU stay and up 90 days post-randomization ] [ Designated as safety issue: No ]

Duration of antibiotics treatment during ICU stay [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Number of readmissions to the ICU [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]

Amount of calories delivered during the ICU stay and in subset markers of feeding intolerence [ Time Frame: during the intervention window of 8 days and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Markers of inflammation such as C-reactive protein concentrations during ICU stay [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Structural and or functional differences in muscle tissue during ICU stay [ Time Frame: during ICU stay and up to 90 days post-randomization ] [ Designated as safety issue: No ]

Premature Newborns ( 37 weeks gestational age upon admission in the PICU)

Prior inclusion in another randomized controlled outcome study

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536275